20121N40

Organization name

nal von minden GmbH

SRN

DE-MF-000013321

Manufacturer status

Active

Primary placement in Germany; available across 27 countries total.

Trade name

not provided

UDI-DI code

04065384000257

Basic UDI-DI

4065384STA1OPS4N1GXEW

Reference / catalog number

20121N40

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

40

Additional product description

The NADAL® Strep A Test is a lateral flow chromatographic immunoassay for the qualitative detection of group A Streptococcus antigens in human oropharyngeal swab specimens. The test is intended for use as an aid in the diagnosis of Streptococcus A (Strep A) infections in patients showing typical symptoms of a local throat infection (see section 12 ‘Limitations’). The test procedure is not automated and requires no special training or qualification. The NADAL® Strep A Test is designed for professional near-patient and laboratory use by healthcare professionals only

Additional information URL

https://www.nal-vonminden.com/

Clinical sizes

No clinical sizes registered for this device.

• W0105090103STREP. A - RT & POC

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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